MedPage Today July 6, 2023
— Feedback is mostly positive, but concerns arise around two-monitor recommendation
As research interest in the therapeutic potential of psychedelics has grown — with academic centers popping up across the country, and compounds already in development — the FDA recently caught up, issuing a draft guidance on managing clinical trials of these drugs.
The draft guidance was released on June 23, as one of the largest U.S. psychedelic conferences was under way. It outlined the agency’s views on best practices in clinical trial design for psychedelic drugs — including psilocybin, lysergic acid diethylamide (LSD), and methylenedioxymethamphetamine (MDMA) — in the treatment of medical conditions including psychiatric or substance use disorders.
In an email to MedPage Today, an FDA spokesperson called...
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